Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168188
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2021-12-02
Brief Title:
The Neuroprotective Effect of PEG-GCSF in the Traumatic Optic Neuropathy
Sponsor:
Buddhist Tzu Chi General Hospital
Organization:
Buddhist Tzu Chi General Hospital
Study Overview
Official Title:
Principle Investigator Initiated Clinical Trial The Neuroprotective Effect of Novel Long-acting Granulocyte-colony-stimulating Factor PEG-GCSF in the Traumatic Optic Neuropathy
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical trial will be a phase 1 semi-experimental trial which will be performed in Hualien Tzu Chi Hospital Twenty patients will be recruited in this study starting from the 2nd year of the project to the 3rd year of the project and will go through comprehensive eye and systemic examination in the Hualien Tzu Chi Hospital Indirect TON ITON patients are defined as reduced best corrected visual acuity BCVA visual field color vision and positive relatively afferent pupillary defect RAPD with normal fundus and optic nerve examination and no evidence of direct trauma to optic nerve on spiral orbital and optic canal computer tomography CT scan Therefore all patients will have examinations of BCVA visual field color vision RAPD FVEP CT scan and IOP for defining ITON patients one day before Neulasta injection Patient also underwent renal function test liver function test coagulation test and complete blood count before the treatment Patients who meet the enrollment criteria inclusion and exclusion will be fully informed of this treatment and then an informed consent will be obtained After patient enrolment the patient will be intravitreally administrated by 015 mL of Neulasta in the injured eye Firstly the injured eye will be treated with iodine solution for disinfection and then will be treated with Alcaine eye drop for topic anesthesia The 015 mL of Neulasta will be filled into 1 mL of syringe equipped with 30 gauge beveled needle for intravitreal injection During injection of Neulasta solution the anterior chamber decompression will be performed for IOP balance The aqueous humor from anterior chamber will be collected for further microarray analysis After Neulasta treatment Tobradex eyedrops Alcon will be given on the injected eye four times a day Patient will be hospitalized for one day to monitor BCVA IOP fundus condition complete blood count and any adverse event During 3-month follow-up trial each patient will be regularly monitored 7 days and 1 3 months after treatments by determining the BCVA the RPAD the color vision visual field the latency of P-100 wave in FVEP and the RNFL thickness IOP and complete blood count
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None